The following drugs and medications are in some way related to, or used in the treatment of Herpes Simplex, Mucocutaneous/Immunocompetent Host. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:
Established name: Tropicamide ophthalmic solution
Chemical name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-.
Each mL contains: Active: Tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH 4.0 - 5.8.
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.
For mydriasis and cycloplegia for diagnostic procedures.
Contraindicated in persons showing hypersensitivity to any component of this preparation.
For topical ophthalmic use only. Not for injection.
This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of intraocular pressure.
Remove contact lenses before using.
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.
Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.
Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
There have been no long-term studies done using Tropicamide in animals to evaluate carcinogenic potential.
Pregnancy Category C. Animal reproduction studies have not been conducted with Tropicamide. It is also not known whether Tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tropicamide is administered to a nursing woman.
Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS). Keep this and all medications out of the reach of children.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of Tropicamide. Increased intraocular pressure has been reported following the use of mydriatics.
Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of Tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.
For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
3mL and 15mL in plastic DROP-TAINER* dispensers.
0.5% - 15 mL: NDC 61314-354-01
1% - 3 mL: NDC 61314-355-01
1% - 15 mL: NDC 61314-355-02
STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed.
Rx Only
Revised: August 2004
*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.
345310-0804
Dist. by:
FALCON Pharmaceuticals, Ltd
Fort Worth, TX 76134
Mfd. by:
ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA
Printed in USA
NDC 61314-354-01 Rx Only
FALCON PHARMACEUTICALS®
Tropicamide
Ophthalmic
Solution USP
0.5%
15 mL STERILE
AFFILIATE OF
ALCON LABORATORIES, INC.
QUALITY RX
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA084305 | 06/09/2000 | |
| Tropicamide Tropicamide solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA084306 | 06/13/2000 | |
| Labeler - Falcon Pharmaceuticals, Ltd. (874345820) |
| Registrant - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
Rx Only
DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each cloth of Prascion® FC (sodium sulfacetamide USP 10% and sulfur USP 5%) Facial Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of sodium sulfacetamide USP and 50 mg of sulfur USP. The cleanser base consists of: butylated hydroxytoluene NF, cetyl alcohol NF, disodium oleamido MEA sulfosuccinate, edetate disodium USP, fragrance, glyceryl stearate/PEG-100 stearate, glycerin USP, methylparaben NF, propylparaben NF, purified water USP, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate USP, stearyl alcohol NF.
CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
INDICATIONS: Prascion FC Facial Cleansing Cloths are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS: Prascion FC Facial Cleansing Cloths are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This drug is not to be used by patients with kidney disease.
WARNINGS: Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Information for Patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy - Category C. Animal reproduction studies have not been conducted with Prascion® FC Facial Cleansing Cloths. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Nursing Mothers - It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Prascion FC Facial Cleansing Cloths. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing woman.
Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.
DOSAGE AND ADMINISTRATION:
Prascion FC Facial Cleansing Cloths: Wash affected areas with cleansing cloth once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10-20 seconds avoiding eyes. Rinse thoroughly and pat dry. Throw away cloth. Do not flush.
HOW SUPPLIED: Prascion® (sodium sulfacetamide 10% and sulfur 5%) Facial Cleansing Cloths are available in
boxes of 30 cloths (3.7 g each) NDC 66993-905-30
boxes of 60 cloths (3.7 g each) NDC 66993-905-60
Store at 15°-25°C (59°- 77°F).
Manufactured for: Prasco Laboratories
Mason, Ohio 45040 USA
Manufactured by: Groupe Parima, Inc
Montreal, QC H4S 1X6 CANADA
| PRASCION FC sodium sulfacetamide and sulfur cloth | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 08/08/2011 | ||
| Labeler - Prasco Laboratories (065969375) |
| Registrant - Groupe PARIMA, Inc. (252437850) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Groupe PARIMA, Inc. | 252437850 | manufacture | |
Relieving nasal congestion due to colds, flu, hay fever, and other allergies. It may also be used for other conditions as determined by your doctor.
Phenylephrine Solution is a decongestant. It works by shrinking swollen and congested nasal tissues by constricting blood vessels. This results in relief of congestion (stuffy feeling) and improved breathing through the nose.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Phenylephrine Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Phenylephrine Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Phenylephrine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Phenylephrine Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Burning or stinging in nose; dizziness; headache; increased discharge from nose; sneezing.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Phenylephrine Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Phenylephrine Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Numbing the skin before certain medical procedures. It may also be used for other conditions as determined by your doctor.
Lidocaine/Tetracaine Patch is a local anesthetic. It works by blocking nerves from sending pain signals to the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Lidocaine/Tetracaine Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Lidocaine/Tetracaine Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lidocaine/Tetracaine Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Lidocaine/Tetracaine Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Lidocaine/Tetracaine Patch.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Abnormal skin sensations; pale skin, redness, or swelling at the application site.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); burning, irritation, or severe redness or swelling at the application site.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Lidocaine/Tetracaine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred or double vision; chest pain; confusion; dizziness; mental or mood changes; ringing in the ears; seizures; slow or irregular breathing; slow or irregular heartbeat; tremors; unusual sensations (eg, feeling of being unusually hot or cold); unusual or severe drowsiness; vomiting. Lidocaine/Tetracaine Patch may be harmful if swallowed.
Store Lidocaine/Tetracaine Patch at room temperature, at 77 degrees F (25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lidocaine/Tetracaine Patch out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Lidocaine/Tetracaine Patch. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.
Hydrochlorothiazide Capsules is a thiazide diuretic. It works by helping the kidneys to remove fluid from the body.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Hydrochlorothiazide Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Hydrochlorothiazide Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrochlorothiazide Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Hydrochlorothiazide Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Hydrochlorothiazide Capsules.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; light-headedness; loss of appetite; nausea; temporary blurred vision.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased urination; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased thirst; joint pain, swelling, warmth, or redness (especially of the big toe joint); muscle pain, weakness, or cramps; numbness or tingling; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; severe or persistent nausea or stomach pain; shortness of breath; symptoms of low blood sodium levels (eg, confusion, mental or mood changes, seizures, sluggishness); unusual bruising or bleeding; unusual drowsiness, restlessness, tiredness, or weakness; unusually dry mouth; vision changes (eg, decreased vision clearness); vomiting; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Hydrochlorothiazide side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, dry mouth or eyes; decreased urination; fast heartbeat; unusual thirst, tiredness, or weakness).
Store Hydrochlorothiazide Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydrochlorothiazide Capsules out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Hydrochlorothiazide Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Nu-Seals 300
Aspirin 300mg Gastro-resistant Tablets
Acetylsalicylic Acid 300mg
White, gastro-resistant tablets, coded “300” in red or “GP” in black
Aspirin has analgesic, antipyretic and anti-inflammatory actions. It can also be used for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery (see below).
Aspirin has an anti-thrombotic action, mediated through inhibition of platelet activation, which has been shown to be useful in secondary prophylaxis following myocardial infarction, and in patients with unstable angina or ischaemic stroke including cerebral transient attacks.
Nu-Seals 300 is indicated wherever high and prolonged dosage of aspirin is required. The special coating resists dissolution in gastric juice, but will dissolve readily in the relatively less acid environment of the duodenum. Owing to the delay that the coating imposes on the release of the active ingredient, Nu-Seals 300 is unsuitable for the short-term relief of pain.
Nu-Seals 300 is for oral administration to adults only.
Analgesic, antipyretic and anti-inflammatory actions: The usual dose of aspirin is 300-900mg repeated three to four times daily according to clinical needs. In acute rheumatic disorders the dose is in the range of 4-8 g daily, taken in divided doses.
Antithrombotic action: Patients should seek the advice of a doctor before commencing therapy for the first time. The usual dosage, for long-term use following myocardial infarction, transient ischaemic attack, or in patients with unstable angina, is 75-150mg once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor.
The elderly: Analgesic, antipyretic and anti-inflammatory actions: As for adults. The elderly are more likely to experience gastric side-effects and tinnitus. Antithrombotic action: The risk-benefit ratio has not been fully established.
Children: Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki's disease). See 'Special Warnings and Special Precautions for Use'.
Hypersensitivity to aspirin. Hypoprothrombinaemia, haemophilia and active peptic ulceration or a history of peptic ulceration.
There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki's disease).
Before commencing long-term aspirin therapy for the management of cerebrovascular or cardiovascular disease patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.
Aspirin decreases platelet adhesiveness and increases bleeding time. Haematological and haemorrhagic effects can occur, and may be severe. Patients should report any unusual bleeding symptoms to their physician.
Salicylates should be used with caution in patients with a history of peptic ulceration or coagulation abnormalities. They may also induce gastro-intestinal haemorrhage, occasionally major.
They may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects.
Aspirin should be used with caution in patients with impaired renal or hepatic function (avoid if severe), or in patients who are dehydrated.
Patients with hypertension should be carefully monitored.
Salicylates may enhance the effect of oral hypoglycaemic agents, phenytoin and sodium valproate. They inhibit the uricosuric effect of probenecid and may increase the toxicity of sulphonamides.
Aspirin may potentiate the effect of heparin and increases the risk of bleeding with oral anticoagulants, antiplatelet agents and fibrinolytics.
Plasma salicylate concentrations may be reduced by concurrent use of corticosteroids, and salicylate toxicity may occur following withdrawal of the corticosteroids. The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered.
Concurrent use of aspirin and other NSAIDs should be avoided. Use of two or more NSAID preparations increases the risk of serious gastrointestinal haemorrhage.
Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity.
In large doses, salicylates may also decrease insulin requirements.
Patients using gastro-resistant aspirin should be advised against ingesting antacids simultaneously to avoid premature drug release.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Pregnancy: Although clinical and epidemiological evidence suggests the safety of aspirin for use in pregnancy, caution should be exercised when considering use in pregnant patients. Aspirin has the ability to alter platelet function and there may be a risk of haemorrhage in infants whose mothers have consumed aspirin during pregnancy. Prolonged pregnancy and labour, with increased bleeding before and after delivery, decreased birth weight and increased rate of stillbirth have been reported with high blood salicylate levels. With high doses there may be premature closure of the ductus arteriosus and possible persistent pulmonary hypertension in the newborn. Analgesic doses of aspirin should be avoided during the last trimester of pregnancy.
Lactation: As aspirin is excreted in breast milk, Nu-Seals should not be taken by patients who are breast-feeding, as there is a risk of Reye's syndrome in the infant. High maternal doses may impair platelet function in the infant.
None known.
Gastrointestinal irritation is common in patients taking aspirin preparations, and nausea, vomiting, dyspepsia, gastritis, gastrointestinal erosions and ulceration have been reported. Anaemia may occur following chronic gastrointestinal blood loss or acute haemorrhage.
Aspirin prolongs bleeding time, and bleeding disorders, such as epistaxis, haematuria, purpura, ecchymoses, haemoptysis, gastrointestinal bleeding, haematoma and cerebral haemorrhage have occasionally been reported. Fatalities have occurred.
Hypersensitivity reactions include skin rashes, urticaria, angioedema, asthma, bronchospasm and rarely, anaphylaxis.
Other side effects: urate kidney stones and tinnitus.
Salicylate poisoning is usually associated with plasma concentrations>350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiogenic pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations>700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years and over 70 have increased risk of salicylate toxicity, and may require dialysis at an earlier stage.
Aspirin has analgesic, antipyretic and anti-inflammatory actions.
It also has antithrombotic action, which is mediated through inhibition of platelet activation.
Nu-Seals 300 tablets have a gastro-resistant coat sandwiched between a sealing coat and a top coat. The gastro-resistant coat is intended to resist gastric fluid whilst allowing disintegration in the intestinal fluid.
Owing to the delay that the coating imposes on the release of the active ingredient, Nu-Seals 300 is unsuitable for the short-term relief of pain.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
In a bioequivalence study comparing the pharmacokinetics of the 300mg product with 4 x 75mg presentation in human volunteers, measures such as terminal phase half-life, area-under-the curve and peak plasma concentrations were recorded on days 1 and 4. On day 1 salicylate reached a peak plasma concentration of between 10.34 and 31.57 mcg/ml and between 11.76 and 27.47mcg/ml for the 300mg and 75mg tablets respectively. Time to peak concentration ranged from 4 to 8 hours and from 3 to 6 hours respectively. AUC ranged from 54.0 to 131.2 and from 64.3 to 137.6 h.mcg/ml respectively. The terminal phase half-life ranged from 1.33 to 2.63 hours and from 1.47 to 2.59 hours respectively. On day 4 Cmax varied from 15.01 to 48.97 mcg/ml for the 300mg tablet and from 11.26 to 60.21 mcg/ml for 4 x 75mg tablets. Tmax ranged from 4 to 8 hours and from 3 to 8 hours, whilst AUC ranged from 89.8 to 297.4 h.mcg/ml and from 61.5 to 293.4 h.mcg/ml respectively.
There are no pre-clinical data of relevance to the prescriber in addition to that summarised in other sections of the Summary of Product Characteristics.
Maize Starch
Hypromellose
Talc
Methacrylic acid – ethyl acrylate (1:1) copolymer dispersion 30 per cent
Polyethylene Glycol 3350
Propylene Glycol
Benzyl Alcohol
Emulsion silicone
Edible Printing Ink – containing either: E124 Red and Shellac or: E172 Black, Shellac and E322 Lecithin
None
2 years
Do not store above 25°C. Keep containers tightly closed.
HDPE bottles with screw caps containing 14, 56, 100 or 500 tablets.
None
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
PL 16853/0063
Date of first authorisation: 22 May 1973
Date of last renewal of authorisation: 12 May 2006
10th August 2010
Alcohol Denat. (anhydrous) 62%
Antiseptic
For external use only. Keep out of eyes. If contact with eyes occurs, rinse promptly and throughly with water.
Flammable. Keep away from fire or flame.
Stop use and ask a doctor if significant irritation or sensitization occurs.
Keep out of reach of children. In case of accidental
ingestion, seek professional assistance
or consult a poison control center immediately.
Questions or comments?
1-800-760-3236 (Mon to Fri 8:30 AM - 5:00 PM EST)
Aplicare Antiseptic Gel Hand Rinse 4 oz
| Aplicare Antiseptic Gel Hand Rinse antiseptic gel hand rinse gel | ||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333 | 08/01/2006 | |
| Labeler - Aplicare, Inc. (107255002) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Aplicare, Inc. | 058377631 | manufacture | |
Class: Antihistamines
VA Class: GA700
Chemical Name: N-(p-[2-(Dimethylamino)ethoxy]benzyl)-3,4,5,-trimethoxybenzamide monohydrochloride
CAS Number: 554-92-7
Brands: Tigan
Antiemetic agent.100 101 a
Control of nausea and vomiting,a including treatment of postoperative nausea and vomiting.100 101 a
Treatment of nausea associated with gastroenteritis.100 101 a
Less effective than phenothiazines, but may be associated with fewer adverse effects.a
Administer orally or by IM injection.100 101 a
Not recommended for IV administration.100 101 a
Preparation for rectal administrationc is no longer commercially available in the US;102 103 FDA has withdrawn approval of the new drug application (NDA) for the rectal suppositories because of lack of substantial evidence of efficacy.102 103 (See Preparations.)
Minimize local adverse effects by injecting deep into the upper outer quadrant of the gluteus maximus; avoid local infiltration of the solution along the needle track.100 101 a
Available as trimethobenzamide hydrochloride; dosage expressed in terms of the salt.100 101 a
Children weighing 13.6–45 kg: 100 or 200 mg 3 or 4 times daily; alternatively, children may receive 15–20 mg/kg daily given in 3 or 4 divided doses.a However, suitable oral dosage forms are no longer commercially available in the US.a
Usual dosage: 300 mg 3 or 4 times daily.100 a Adjust dosage according to indication for use, severity of symptoms, and patient response.100
Usual dosage: 200 mg 3 or 4 times daily.100 101 a Adjust dosage according to indication for use, severity of symptoms, and patient response.100 101
No special population dosage recommendations at this time.100 101
Known hypersensitivity to trimethobenzamide.100 101 a c
Injection contraindicated in children.100 101 a
May impair ability to perform activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle); avoid concomitant use with alcohol.100 101 a c
Possible neurologic reactions (e.g., opisthotonos, seizures, coma, extrapyramidal reactions); may be similar to CNS signs and symptoms accompanying certain disorders (e.g., acute febrile illness, encephalitis, Reye’s syndrome, encephalopathy, gastroenteritis, dehydration, electrolyte imbalance), especially in children and in geriatric or debilitated patients.100 101 a c Diagnosis of these disorders may be obscured or the disease-associated signs and symptoms may be incorrectly diagnosed as drug induced.100 101 a c
Use with caution in patients with such disorders, particularly in those who have recently received other CNS drugs (e.g., phenothiazines, barbiturates, belladonna derivatives).100 101 a c (See Specific Drugs under Interactions.)
Avoid use in pediatric patients with signs and symptoms suggestive of Reye’s syndrome.100 101 a c (See Pediatric Use under Cautions.)
Discontinue drug if CNS symptoms occur.100 101 a c
Hypersensitivity reactions including allergic skin reactions have been reported; discontinue at the first sign of sensitization.100 101 a c
Jaundice reported; discontinue drug if jaundice occurs.100 101 a c
Potential hepatotoxic effects may unfavorably alter the course of Reye’s syndrome.100 101 a c (See Pediatric Use under Cautions.)
Blood dyscrasias reported; discontinue drug if blood dyscrasia occurs.100 101 a c
Antiemetic effect may mask signs of overdosage of other drugs or may obscure the cause of vomiting in various disorders (e.g., appendicitis).100 101 a c
Discontinue drug if exaggeration of preexisting nausea occurs.100 101 a c
Category C.e
Not known whether trimethobenzamide is distributed into milk.a e Safety not established.100 101 a c
Injection contraindicated in children.100 101 a Suitable oral dosage forms and rectal suppositories for pediatric use no longer are commercially available in the US.102 103 a c (See Preparations.)
Use trimethobenzamide with caution in children.a c Not recommended for treatment of uncomplicated vomiting in children; limit use to treatment of prolonged vomiting of known etiology.100 101 c Avoid use in pediatric patients with signs and symptoms suggestive of Reye’s syndrome.100 101 a c
Extrapyramidal effects of trimethobenzamide may obscure the diagnosis of or be confused with CNS manifestations of Reye’s syndrome or other encephalopathies.100 101 a c (See Neurologic Effects under Cautions.)
Potential hepatotoxic effects of trimethobenzamide may unfavorably alter the course of Reye’s syndrome.100 101 a c
Children with acute febrile illnesses, encephalitides, gastroenteritis, dehydration, or electrolyte imbalance may be at increased risk for adverse CNS effects (e.g., extrapyramidal reactions, opisthotonos, seizures, coma).100 101 a c Use with caution in such children, especially those who recently have received other CNS agents.100 101 a c
Geriatric and debilitated patients with acute febrile illnesses, encephalitides, gastroenteritis, dehydration, or electrolyte imbalance may be at increased risk for adverse CNS effects (e.g., extrapyramidal reactions, opisthotonos, seizures, coma).100 101 a c Use with caution in such individuals, especially those who recently have received other CNS agents.100 101 a c
Adverse effects may include blurred vision,100 101 a c depression,100 101 a c disorientation,100 101 a c dizziness,100 101 a c drowsiness,100 101 a c headache,100 101 a c extrapyramidal symptoms,100 101 a c diarrhea,100 a c opisthotonos,100 101 a c and muscle cramps.100 101 a c In addition, injection site reactions (pain,100 101 a stinging,100 101 a redness,100 101 a swelling100 101 a ) and hypotension100 101 a may occur following IM injection.
Drug | Interaction | Comments |
Alcohol | Impaired mental alertness/physical coordination100 101 a | Avoid concomitant usea |
CNS drugs (e.g., barbiturates, belladonna derivatives, phenothiazines) | Possible increased risk of CNS reactions100 101 a c | Use with cautiona |
Relative bioavailability of oral capsule compared with IM injection is 100%.100 101 a Peak plasma concentration attained within 30 minutes after IM injection or 45 minutes after oral dose.100 101
10–40 minutes after oral administration; 15–35 minutes after IM injection.a
3–4 hours after oral administration; 2–3 hours after IM injection.a
300-mg oral dose equivalent to a 200-mg IM dose.100 101 a
Distribution into human body tissues and fluids has not been determined.a Drug and metabolites are distributed mainly into liver, kidneys, and lungs in animals.a
30–50% of a single dose excreted in urine as unchanged drug within 48–72 hours following administration.a
7–9 hours.100 101 a
25°C (may be exposed to 15–30°C).100 c
20–25°C.100 101
Appears to directly affect the medullary chemoreceptor trigger zone (CTZ) by inhibiting stimuli at the CTZ.100 101 a c
Inhibits the emetic effect of apomorphine in animals; however, does not appear to inhibit direct impulses to the vomiting center in the lateral reticular formation and does not act peripherally to decrease the sensitivity of visceral nerves that transmit afferent impulses from the GI tract to the vomiting center.100 101 a c
Structurally related to the substituted ethanolamine antihistamines (e.g., diphenhydramine) but exhibits only weak antihistaminic activity.a
Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.100 101 a c Avoid concomitant use of alcohol.100 a
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.100 101 a c
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 101 a c
Importance of informing patients of other important precautionary information.100 101 a e (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
In April 2007, FDA announced that the agency was withdrawing approval of the NDA for trimethobenzamide hydrochloride (Tigan) suppositories because of lack of substantial evidence of efficacy.102 103 FDA also announced that it would take enforcement action against all firms attempting to manufacture or distribute trimethobenzamide-containing suppositories after May 9, 2007, without an approved application.102 103 Any firm seeking to market this formulation must obtain an approved NDA prior to marketing.102 103
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 300 mg* | Tigan | Monarch |
Trimethobenzamide Hydrochloride Capsules | Amide | |||
Parenteral | Injection, for IM use only | 100 mg/mL* | Tigan (with phenol in multiple-dose vials and preservative-free in single-dose vials) | Monarch |
Trimethobenzamide Hydrochloride Injection Carpuject (with phenol) | Hospira |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Tigan 300MG Capsules (MONARCH PHARMACEUTICALS): 30/$60.99 or 90/$174.97
Trimethobenzamide HCl 300MG Capsules (MUTUAL PHARMACEUTICAL): 30/$50.99 or 90/$129.98
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
100. Monarch Pharmaceuticals, Inc. Tigan (trimethobenzamide hydrochloride) capsules and injection prescribing information. Bristol, TN; 2006 Jul.
101. Hospira, Inc. Trimethobenzamide hydrochloride injection prescribing information. Lake Forest, IL; 2004 Oct.
102. US Food and Drug Administration. FDA announces that companies must stop marketing suppository products containing trimethobenzamide. Rockville, MD; 2007 Apr 6. Press release No. P07-58.
103. Food and Drug Administration. Trimethobenzamide hydrochloride suppositories; withdrawal of approval. Notice. [Docket No. 1978N-0224 (formerly Docket No. 78N-0224); DESI 11853]. Fed Regist. 2007; 72:17556-8.
a. AHFS drug information 2007. McEvoy GK, ed. Trimethobenzamide hydrochloride. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007:2938-40.
c. G & W Labs, Inc. Trimethobenzamide HCI suppositories with benzocaine prescribing information. South Plainfield, NJ; 2001 Jun.
e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1631-2.
